Identity
- Device Name
- Anesthesia Masks for Single Use EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948097057344 EUDAMED
- Basic UDI-DI
- 6948097014MZMZJR EUDAMED
- EMDN Code
- Z1203010101 ANAESTHESIA DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Anesthesia Masks for Single Use by Haiyan Kangyuan Medical Instrument Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6948097014MZMZJR | Class IIa | Active |
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Manufacturer
- Manufacturer
- Haiyan Kangyuan Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000001532
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED bceab3fe-3208-4c3b-b389-1c230864940d 61 fields · synced Aug 2, 2026